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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K020140
Device Name VOXAR'S CALCIUM SCORING PRODUCT
Applicant
Voxar Limited
Bonnington Bond, 2 Anderson Pl.
Edinburgh, Lothian,  GB EH6 5NP
Applicant Contact CONRAD CMIN
Correspondent
Underwriters Laboratories, Inc.
12 Laboratory Dr.
Research Triangel Park,  NC  27709
Correspondent Contact JEFF D RONGERO
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received01/16/2002
Decision Date 01/28/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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